Industry Insights

The global extracellular matrix (ECM) patches market size was valued at USD 22.08 million in 2017 and is projected to expand at a CAGR of 7.7% over the forecast period. Increasing incidence of congenital heart disease (CHD) and trauma injuries, several of which often result in repair and reconstruction procedures, is one of the key factors driving the market. According to the Centers for Disease Control and Prevention (CDC), about 40,000 neonates are born with CHD in U.S. each year.

Increasing adoption of extracellular matrix in hernia and pelvic reconstruction surgeries promotes the growth of these products. For instance, abdominal wall hernia is amongst the commonest surgeries around the world. Many companies are focusing on development of extracellular matrix for pelvic reconstruction and hernia repair. For instance, Xenform Soft Tissue Repair Matrix, manufactured by Boston Scientific Corporation, is indicated for soft tissue regeneration particularly in case of pelvic organ prolapse. Similarly, Permacol Surgical Implant manufactured by Medtronic is used for the repair of ventral hernia and restoration of abdominal wall.

Recent technological advancements in extracellular matrix for soft tissue repair and wound healing procedures propels product demand. For instance, AltiPly, manufactured by Aziyo Biologics, is a ready-to-use patch that requires no rehydration and ensures ease in handling at room temperature. It is used in cases of venous leg ulcers, diabetic foot ulcers, and pressure wounds and involves proprietary processing that improves growth level factors and enhances the healing process.

High cost of these ECM grafts may negatively impact market growth. However, reimbursement assistance from governments for their will continue to drive demand. For instance, eight Current Procedural Terminology (CPT) codes have been identified by the American Medical Association for various applications of OASIS Matrix products, manufactured by Smith & Nephew. The product can be reimbursed in three settings: out of hospital (HOPD), physician in-office (QHP), and ambulatory wound care center (ASC).

Rising awareness of the benefits of biological patches over synthetic ones is also one of the significant factors contributing to the growth of ECM patches. However, in the past few years, many of these products have undergone recalls, which in turn, hinder its adoption levels. In addition, the use of extracellular matrix grafts involves various complications such as allergies, chronic inflammation, pain, swelling, and redness, which may adversely impact its growth.

Application Insights

In 2017, the soft tissue repair segment accounted for the largest revenue share. Increasing number of hernia repair surgeries–particularly inguinal hernia, rising prevalence of trauma surgeries, and high treatment rates are some of the important factors that propel the market. In addition, growing adoption and awareness of extracellular matrix among healthcare providers, especially in developed countries, is expected to drive the application segment.

For instance, Medeor Matrix manufactured by Koninklijke DSM N.V. is used for various soft tissue applications such as pelvic floor reconstruction, plastic and reconstructive surgeries, and abdominal wall repair. It is manufactured using the OPTRIX process, which eliminates cells, inactivates viruses, disinfects tissues, and preserves ECM components.

ECM patches for vascular repair and reconstruction is projected to expand at the fastest CAGR of 11.4%. Rising number of vascular surgeries, increasing prevalence of vascular diseases, and surging geriatric population are among the important factors anticipated to boost demand over the forecast period. In addition, many public and private organizations are supporting research studies in the area of extracellular matrix to treat vascular conditions, which may further propel the segment. For instance, the European Society for Vascular Surgery promotes high quality research and advises regulatory bodies on matters concerning vascular diseases. It shares partnerships with various ECM patch manufacturers, including Medtronic, Boston Scientific Corporation, Cook Medical, and Smith & Nephew.

Raw Material Insights

In 2017, porcine accounted for the largest revenue share in the ECM patches market owing to high usage of these grafts in repair and reconstructive surgeries. These porcine-derived grafts offer several benefits such as durability, pliability, and minimal scar formation, which spurs their demand. Moreover, wide availability of these grafts and high adoption levels drive segment growth.

ECM patches derived from bovine sources is projected to register a CAGR of 8.3%. Rising number of bovine-based products, coupled with growing applications in soft tissue repair, vascular repair and reconstruction, dural repair, pericardial repair, and others, have led to increase in demand of these products. Furthermore, these patches are preferred over other materials as they offer superior biocompatibility, reduced risk of infection, and ease in handling during surgical procedures.

ECM patches derived from other sources, such as human derived dermis and equine derived pericardium, also held a significant market share in 2017. Increasing number of research studies by private companies, coupled with high investments in R&D, enable the adoption of other raw materials for manufacturing of ECM patches. Moreover, many public and private organizations are supporting the development of ECM grafts through donation of human dermis. For instance, MTF Biologics is a non-profit organization engaged in providing human allograft tissue. One of its products, AlloPatch HD Acellular Dermis, is a human allograft derived from donated human tissue.

Regional Insights

North America held the largest revenue share in 2017. Increasing incidence of cardiovascular diseases and defects, sports injuries, and trauma cases are responsible for the growing demand in this region. According to latest estimates by the American Association for the Surgery of Trauma, each year, about 150,000 deaths were reported due to injuries in U.S. Presence of a large number of market players further increases the availability of ECM patches in this region.

Presence of technologically advanced research labs, increasing amount of research funds, and high healthcare expenditure are among the significant factors contributing toward the growth of this regional market. Higher adoption and awareness of advanced ECM patches among healthcare providers and patients further impels demand. Favorable reimbursement policies will also boost market growth.

Asia Pacific is expected to register the highest CAGR of 9.7% over the forecast period. High prevalence of cardiovascular diseases, increasing incidence of trauma, and rising number of surgeries may propel the market. Rising healthcare expenditure and growing disease burden are likely to boost demand in the coming years. However, high cost of the product may negatively impact the growth in this region.

Extracellular Matrix (ECM) Patches Market Share Insights

Aziyo Biologics; Boston Scientific Corporation; Coloplast; DSM; and Baxter are some of the key players operating in this market. Market players are undergoing mergers and acquisitions to acquire new technologies for ECM patch manufacturing. In addition, many of these players are entering into partnerships and agreements for marketing and distribution of these products. For instance, MTF Biologics entered into a partnership with CONMED Corporation in 2012. Due to this partnership, CONMED Linvatec became their global marketing representative for sports- and extremity-related allograft tissues.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the global extracellular matrix (ECM) patches market report on the basis of application, raw material, and region: